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An IBC, with its associated process, is required for all companies and institutions receiving National Institutes of Health (NIH) funding. Additionally, local regulations may require that institutions engaged in rDNA research have an IBC regardless of NIH funding. The scale of an IBC is directly proportional to the number of research projects being managed. Small biotech companies can require little ongoing management once a solid foundation is put in place. Large research institutions that apply often for NIH funding for research projects will require much more complex systems and processes to maintain their compliance status. EH&E can offer help across this wide spectrum of coverage to keep you in compliance, and to protect you from funding delays caused by insufficient program elements. On behalf of the institution, EH&E can work with institutional staff to manage your local IBC. Management can be conducted with onsite support or remotely through EH&E’s web-based Research Protocol Review Management system. By outsourcing the management of your IBC, you ensure that the IBC will be run by EH&E staff knowledgeable in the applicable regulations and allow institutional staff to focus on other tasks. EH&E’s experienced biosafety officers can provide the following IBC services: - Development of IBC policies, procedures and registration documents.
- Training of IBC members on the requirements of the NIH Guidelines and the review of protocols.
- Registering IBC with the NIH and applicable local government agencies, as necessary.
- Provide reviews of IBC protocols to ensure compliance with all regulatory and safety guidance.
- Assessment of facilities, procedures, practices and training of research and/or manufacturing staff.
- Schedule IBC meetings.
- Assist in identifying local IBC membership.
- Generate meeting materials, such as agendas, meeting minutes, and NIH annual reports.
- Assistance in preparation of materials required for submission to NIH Recombinant DNA Advisory Committee (RAC) for human gene transfer studies.
- Guidance on Appendix M requirements include serious adverse event (SAE) reporting to NIH.
- Investigate incidents involving biological materials to determine whether or not NIH reporting is required.
- SAE and laboratory incident reporting to NIH.
EH&E can help you put in place a solid IBC program or assist with streamlining your existing process via expertise and software support. To find out more about EH&E’s IBC services, email us at contact@eheinc.com or call 1-800-825-5343.
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